Packaging system

ABSTRACT

A packaging system for hydrating sterile devices without comprising the integrity of the sterilization. The packaging system may include an enclosure for enclosing a device requiring hydration, a container containing a hydrate, a base located within the interior of the enclosure and an activating member located within the interior of the enclosure. The container and the device may be located within a receptacle. The receptacle may rest on the base and the activating member may be affixed on top of the receptacle. A force may be exerted on an exterior portion of the enclosure such that the activating member pushes on the receptacle and crushes or ruptures the container. The hydrate located within the container is then released to the device, thereby hydrating the device without breaking the seal of the enclosure. The sterilized environment is therefore maintained and the device is hydrated.

CROSS-REFERENCE TO RELATED APPLICATIONS

Embodiments of the present invention relate to U.S. ProvisionalApplication Ser. No. 60/414,288, filed Sep. 27, 2002, entitled“Packaging System,” which is incorporated by reference herein and is abasis for a claim of priority.

BACKGROUND

1. Field of the Invention

This invention relates to the field of packaging and, in particular, topackaging, systems and processes capable of hydrating contents of apackage or exchanging fluids within the package while, in someembodiments, maintaining a sterile environment within the package.

2. Description of Related Art

Many devices in the sensing arts and other areas of technology requirehydration for proper operation. Although such devices may be stored in adehydrated state for a variety of reasons, hydration is required toeffectively utilize the devices.

Some applications also require that sensors be sterilized, such as, forexample, an in vivo biological parameter sensor. Traditionally, thecombination of hydrating and sterilizing an in vivo biological parametersensor has been troublesome. Sterilization of in vivo biologicalparameter sensors is frequently accomplished by exposure of the sensorto ethylene oxide (EtO) gas. However, if a sensor has been hydrated andis then sterilized using EtO, exposure of the hydrate to EtO could causethe hydrate to become toxic, which, in turn, would cause the sensor tobecome toxic and would render it unsuitable for in vivo implantation.Thus, hydration and sterilization have traditionally been at odds witheach other.

Other applications require that a sensor or other device requiringhydration for activation be hydrated by the sensor manufacturer. Becausestate of the art sensor technology may place too great a demand on thecapabilities of an end user to effectively hydrate a sensor, sensorhydration is best accomplished by the manufacturer having sophisticatedcapabilities. However, many devices tend to lose shelf life oncehydration has been effected. For those devices that have been hydratedand then sit on the shelf of the end user for an extended period of timebefore use, the effective life of the device may be limited or even overby the time the device is utilized.

Accordingly, there is a need in industry to provide a system forhydrating sterilized devices without compromising the integrity of thesterilization. There is also a need in industry to provide a system forhydrating devices that allows for maximum shelf life of the device. Thepresent invention satisfies these needs.

SUMMARY

Embodiments of the present invention relate to systems and processes forhydrating sterilized devices without compromising the integrity of thesterilization. Further embodiments of the present invention relate tosystems and processes for hydrating devices that allow for maximum shelflife of the device.

A packaging system and system according to an embodiment of the presentinvention may include an enclosure for enclosing a device requiringhydration and a container containing a hydrate. The container may belocated within the packaging system adjacent to the device. Thecontainer releases the hydrate to the device. The packaging system mayalso include a receptacle located within an interior of the enclosure, abase located within the interior of the enclosure and underneath thereceptacle and an activating member located within the interior of theenclosure and on top of the receptacle.

According to an embodiment of the present invention, the container andthe device requiring hydration may be located within the interior of thereceptacle. Also, the activating member may exert a force on thecontainer to release the hydrate to the device. The force may be appliedto an external portion of the enclosure and may be transferred to thecontainer via the activating member.

According to an embodiment of the present invention, a covering maysurround the container. The covering may be a mesh made from any one ofa variety of materials, including, but not limited to, nylon, paper,DACRON, cotton, polyester, any natural or manmade fiber, otherfiltering-type material, foil or other protective material and the like.The container may be an ampule, a bladder, a sponge, or the like.

The device requiring hydration may reside in a first interior portion ofthe receptacle while the container may reside in a second interiorportion of the receptacle. The hydrate may then flow from the secondinterior portion of the receptacle to the first interior portion of thereceptacle. The hydrate may flow through a channel, tube, valve or othermechanism. The hydrate may be a fluid, liquid, gel, gas, sterilant orthe like, or a combination of hydrates, and may include, withoutlimitation, drugs, activators, solvents or the like.

According to an embodiment of the present invention, a method forhydrating a device may include enclosing the device within a package,providing a container containing a hydrate inside the package andcausing the container to release the hydrate to the device. Causing thecontainer to release the hydrate may include exerting a force on anactivating member, whereby exerting the force on the activating membercauses the container to break or to rupture depending on the nature ofthe container. Before causing the container to release the hydrate tothe device, the device and the package may be sterilized with asterilizing agent, including, but not limited to, a gas, a liquid,radiation or the like. For example, the device and the package may besterilized with a sterilizing process including, but not limited to,ethylene oxide.

The method for hydrating a device may also include placing the containerin a first cavity of a receptacle and placing the receptacle inside thepackage. The device may placed into a second cavity of the receptacle. Abase may be placed inside the package such that the receptacle rests onthe base. An activating member may be affixed on top of the receptaclesuch that a force exerted on an exterior portion of the package worksthrough the activating member to cause the container to release thehydrate.

The method may also include sterilizing the package and the devicebefore causing the container to release the hydrate to the device andhermetically sealing the package. The package and the device may besterilized with ethylene oxide, radiation or other sterilizing agent.

According to an embodiment of the present invention, a packaging systemfor bringing elements located in a package into contact with each othermay include an enclosure for enclosing a first element, a containercontaining a second element, the container located within the packageadjacent to the first element, a base having an inclined surface locatedwithin the enclosure, and a receptacle supported on the inclined surfaceof the base within the enclosure, wherein the container is operable torelease the first element to the second element

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a plan view of a generalized packaging system according toan embodiment of the present invention.

FIG. 2 shows a top view of the packaging system according to anembodiment of the present invention.

FIG. 3 shows a side view of the packaging system according to anembodiment of the present invention.

FIG. 4 shows a top view of a receptacle and the relative position ofelements within the interior of the receptacle according to anembodiment of the present invention.

FIG. 5 shows additional details of the receptacle according to anembodiment of the present invention.

FIG. 6 shows a receptacle with tabs peeled apart according to anembodiment of the present invention.

FIG. 7A shows a container according to an embodiment of the presentinvention.

FIG. 7B shows a covering surrounding a container according to anembodiment of the present invention.

FIG. 8 shows a base according to an embodiment of the present invention.

FIG. 9 shows a method for hydrating a device according to an embodimentof the present invention.

FIG. 10 shows another method for hydrating a device according to anembodiment of the present invention.

FIG. 11 shows a plan view of a generalized packaging system according toanother embodiment of the present invention.

FIG. 12 shows a perspective view of a generalized packaging systemaccording to an embodiment of the present invention.

DETAILED DESCRIPTION

In the following description of preferred embodiments, reference is madeto the accompanying drawings which form a part hereof, and in which areshown by way of illustration specific embodiments in which the inventionmay be practiced. It is to be understood that other embodiments may beutilized and structural changes may be made without departing from thescope of the present invention.

A generalized packaging system 10 according to an embodiment of thepresent invention is shown in FIG. 1. The packaging system 10 includes,without limitation, an enclosure 12, an activating member 14, asubstance container 16 and a receptacle 18. The enclosure 12 may allowsterilant penetration, but not microbe penetration, and generallyincludes enough space within its interior to house a device requiringhydration in addition to the other elements of the packaging system 10.For example, in the embodiment shown in FIG. 1, the enclosure 12 housesa catheter 19 having a sensing element which must be hydrated. A sensingelement suitable for this type of embodiment is disclosed in a patentapplication entitled “Sensing Apparatus and Process,” Ser. No.10/036,093, filed Dec. 28, 2001, which is hereby incorporated byreference, and in a patent application entitled “Sensor Substrate andMethod of Fabricating Same,” Ser. No. 10/038,276, filed Dec. 31, 2001,which is also hereby incorporated by reference.

The packaging system 10, however, is not limited to housing catheters ormedical devices. The packaging system 10 may house any suitablestructure, component or device requiring hydration or activation throughexposure to a fluid or other hydrate. In addition, the packaging system10 may house any elements that must be mixed together or any element towhich a catalyst, solvent or activating agent must be added.

The enclosure 12 may be formed into any suitable shape and size. Forexample, in the embodiment shown in FIG. 1, the enclosure 12 isgenerally rectangular in shape and has a generally rectangular shapedinterior for housing the other elements of the packaging system 10 aswell as the device requiring hydration. However, the enclosure 12 maytake on any shape or size sufficient for its intended application.Moreover, the interior portion of the enclosure 12, which houses theother elements of the packaging system 10 and the device requiringhydration, may also take on any suitable shape or size, so long as thehydration requirements for the device requiring hydration are met.

The enclosure 12 may be made from any suitable material, such as, butnot limited to, opaque or transparent plastic, TYVEK, medical gradepapers or the like. The enclosure 12 also includes a cover 13.Additionally, according to an embodiment of the present invention, theenclosure 12 may be hermetically sealed such that the environment withinthe interior portion of the enclosure 12 remains relatively constant.Accordingly, for applications requiring that the interior of theenclosure 12 be sterilized, an enclosure 12 that is hermetically sealedensures that the integrity of the sterile environment within theenclosure 12 is not compromised.

A top view of the packaging system 10 is show in FIG. 2A while a sideview of the packaging system 10 is shown in FIG. 2B. FIG. 2A shows howthe interior of the enclosure 12 can be a custom geometry to accommodatea particular type of device requiring hydration. Other geometries foraccommodating other devices or for accommodating a variety of differentdevices may be employed in other embodiments of the invention.

Operation of the packaging system 10 can be seen in the view afforded byFIG. 2B. The receptacle 18, which houses the container 16 and the devicerequiring hydration, such as, for example, an end portion of thecatheter 19 shown in FIG. 2A, rests at an angle on the base 20. Affixedon top of the receptacle 18 is the activating member 14. The activatingmember 14 comprises a generally rigid body that extends from the portionof the receptacle 18 directly above the container 16 to the top cover ofthe enclosure 12. As will be explained in more detail below, thecontainer 16 may be filled with a sterile buffer or other liquids. Anexternal force, such as that applied by a thumb or finger, for example,may be applied to the activating member 14 by pressing on top of theenclosure 12. Other force applying devices or mechanisms may also beused, such as, for example, a sponge actuator, a pneumatic bulb-typeactuator, a sliding member or the like. The force applied will activatethe activating member 14 to release liquid from the receptacle 18. Inthe embodiment shown in FIG. 2B, the force applied will push theactivating member 14 to into the receptacle 18, thereby crushing thecontainer 16 and releasing the sterile buffer. Because the receptacle 18rests on an angle on the base 20, the sterile buffer located within thecontainer 16 will be forced to move by gravity toward the devicerequiring hydration that has been positioned inside the receptacle 18.

Details of the example receptacle 18 may be seen in FIG. 3. Thereceptacle 18 may be formed from any suitable material that can holdliquid, such as, but not limited to, soft silicone, rubber, plastic andthe like. The receptacle 18 may include a top layer 19 a of material anda bottom layer 19 b of material which define an internal reservoir 22there between. The internal reservoir 22, which exists within theinterior of the receptacle 18, may, for example, comprise a recess orindentation in one or both of the layers 19 a and 19 b to house a devicerequiring hydration and provide a place for a hydrating fluid toaccumulate. In the embodiment shown in FIG. 3, the receptacle 18 hasbeen fabricated with tabs 24 that allow the receptacle 18 to be pulledapart so that the interior portion of the receptacle 18 may be accessed.The tabs 24 form grip surfaces that allow a user to readily separate thetop layer 19 a from the bottom layer 19 b. The receptacle 18 may alsoprovide an indentation for the container 16, which also exists withinthe interior of the receptacle 18, to reside.

FIG. 4 shows a top view of the receptacle 18 and the relative positionof elements within its interior. As shown in FIG. 4, the tabs 24 arepositioned on one end of the receptacle 18 and are large enough so thata user can pull the tabs apart and reach the internal portion of thereceptacle 18. In the embodiment shown in FIG. 4, the reservoir 22 islocated generally within the interior of the receptacle 18 at a centerportion of the receptacle 18. The container 16 is located within theinterior of the receptacle 18 adjacent to the reservoir 22, therebyminimizing the distance that a hydrating fluid located within thecontainer 16 must travel. However, in other embodiments, the position ofthe elements located within the interior of the receptacle 18 may varyaccording to the application and the requirements of the devicerequiring hydration.

Additional details of the example receptacle 18 may be seen in FIG. 5,which shows a bottom one-half portion of the receptacle 18. In theembodiment of the receptacle 18 shown in FIG. 5, the tabs 24 are offsetfrom one another. The offset of the tabs 24 shown in the embodiment ofFIG. 5 provides easy separation of the receptacle 18 for a user. Alsoshown in the embodiment of the receptacle 18 of FIG. 5, a containerchamber 32 has been formed to accommodate the container being used forthe particular application. The container chamber 32 shown in FIG. 5 isrectangular compression or recess in the bottom layer 19 b. In otherembodiments, the container chamber 32 may have any shape and size thatwill accommodate the container being used.

The receptacle 18 shown in FIG. 5 also includes a groove 30 foraccommodating a catheter or a catheter-like device. The groove 30 iscircular in nature and includes sealing rings, other seals or ribs 36that provide friction for better gripping of the catheter and thatprovide seals for better retention of fluids around the catheter. Othermeans for gripping may be employed in other embodiments, including, butnot limited to, treads, protrusion or other discontinuities on thesurface of the groove 30 or a groove 30 diameter that is slightly lessthan the catheter diameter to provide a friction or compression fit.Alternatively, the groove 30 may be replaced by a cutout or cutouts ofother shapes and sizes to accommodate the shape and the size of thedevice requiring hydration.

A receptacle 18 with the tabs 24 peeled apart is shown in FIG. 6. Withthe tabs 24 peeled apart, the reservoir 22 within the interior ofreceptacle 18 is exposed. The reservoir 22 is large enough toaccommodate the device requiring hydration, in this case, for example, aportion of the catheter. When placed together as shown in FIG. 3, thetabs 24 may be held together in any suitable manner, such as, but notlimited to, an adhesive 40 placed upon a portion of the receptacle 18adjacent to the tabs.

FIG. 7A shows an embodiment of the container 16. The container 16 may bemade from glass, plastic or any material that can be crushed ormanipulated with a minimum amount of force. Alternatively, the container16 need not be sealed container that houses a hydrate. For example,according to other embodiments of the present invention, the container16 may be a bladder, a sponge, squeeze tube or the like. Moreover, thehydrate need not be highly fluidic. For example, the hydrate may be agel that exists within a sponge and is squeezed out of the sponge inresponse to an externally applied force or the hydrate may be asterilized buffer that has been encapsulated in a glass ampule.

If the container 16 takes the form of a bladder, the bladder may beruptured or punctured to release the hydrate to the device requiringhydration. For example, the activating member 14 may be fitted with aneedle or other piercing element that punctures or ruptures the bladderwhen a force is applied to the activating member 14.

In certain example embodiments discussed above, the container 16comprises a crushable material, such as, but not limited to, a glass orplastic ampule, vial or the like. In such embodiments, a covering 42 maysurround the container 16 as shown in FIG. 7B. The covering 42 may be amesh made from a variety of materials, such as, for example, nylon,fabric, cloth, cotton, paper, plastic or the like. The container 42 isformed such that, if the container 16 is crushed to release the hydrate,the hydrate can flow through the filtering mesh to reach the devicerequiring hydration, but broken pieces of the container 16 remain withinthe mesh so as to minimize contamination of the device requiringhydration.

A base 20 according to an embodiment of the present invention is shownin FIG. 8. The base may include, without limitation, a rigid structurehaving a flat or an inclined surface 50 and a support surface 52. Theinclined surface 50 may elevate at any angle sufficient to direct thehydrate into the device requiring hydration once the container 16 iscrushed (or the substance within the container is otherwise released).The support surface 52 is configured to receive accommodate the devicerequiring hydration. Depending on the requirement of the device, otherembodiments need not employ a support surface 52. The actual size andshape of the base 20 may vary according to the size and shape of thedevice requiring hydration and the size and shape of the enclosure 12.For example, the shape of the base 20 could be circular or“bowl-shaped,” with the device requiring hydration residing in thecenter of the base 20.

A method for hydrating a device according to an embodiment of thepresent invention is shown in FIG. 9. At step 60, a container 16containing a hydrate is provided inside a package. At step 62, a devicerequiring hydration or activation, such as a sensing element, forexample, is enclosed within the package. At step 3, and the container 16releases the hydrate to the device. The container 16 may release thehydrate to the device in response to an external force applied directlyor indirectly to the container, for example, through an actuation member14.

A further method for hydrating a device according to an embodiment ofthe present invention is shown in FIG. 10. At step 70, a support base 20is placed inside a package. At step 72, a container 16 containing ahydrate is placed inside a receptacle 18 having a cavity for thecontainer. The container 16 is positioned on the support base such thatthe hydrate inside the container would flow toward the part requiringhydration if the hydrate is released from the container 16.

At step 74, a device requiring hydration is also positioned within thereceptacle 18, the device being position adjacent to the container 16.The receptacle 18 may also include a cavity for receiving the devicerequiring hydration.

At step 76, the receptacle 18, with the device requiring hydration andthe container 16, are placed inside the package and on top of thesupport base. The receptacle 18 is positioned on the support base suchthat the hydrate inside the container 16 would flow away from thecontainer 16 and toward the device, if the hydrate is released from thecontainer 16.

At step 78, an activating member 14 may be placed on top of thereceptacle 18. The activating member may be pushed by an external forceto crush, pierce, squeeze or otherwise cause the container to releasethe hydrate.

At step 80, the package is sealed. If the package and its contents havebeen sterilized, the package may be hermetically sealed so that theeffects of sterilization are not compromised

At step 82, the package and all elements contained within the packageare sterilized. Any suitable technique may be used to sterilize thepackage and its contents. For example, the package and its contents maybe exposed to ethylene oxide (EtO) or may be irradiated. If the devicerequiring hydration is an in vivo sensing element, such as, for example,a glucose oxidase enzyme, a protein or antibody element, the sensingelement will then be suitable for in vivo implantation.

However, EtO sterilization may be detrimental to the hydrate. Forexample, if the hydrate is a sterilized buffer, exposure of thesterilized buffer to EtO may turn the sterilized buffer into a toxicfluid. If the sterilized buffer were to become toxic, it would beunsuitable for hydration of the device, especially if the device were anin vivo sensing element. Accordingly, when using EtO as a sterilant orother sterilizing agent for the package and its contents, the containercontaining the hydrate should be sufficient to protect the hydrate fromcontamination by the sterilant. Accordingly, the container may be made,for example, from a non-porous material. For example, if the hydrate iscontained in a glass ampule, the deleterious effects that exposure ofthe hydrate to EtO or other sterilant may be minimized. For a lightsterilant or chemical sterilant, the container may be made, for example,from foil or treated glass.

At step 84, the activating member 14 is activated to release hydrate todevice. For example, activation of the activating member may be assimple as pushing on an external portion of the package with a thumb orfinger such that the force of the pushing is transferred through thepackage to the receptacle 18, then through the receptacle 18 to thecontainer 16 to crush the container 16 or otherwise expel hydrate fromthe container 16. When the hydrate is released from the container 16 inembodiments of the invention relying on gravity, the hydrate will traveltoward the device requiring hydration due to the slope of the base 50 onwhich the receptacle 18 sits. For other embodiments of the invention,valves or other devices may be used to hydrate the device. In stillother embodiments of the present invention, the system may be fabricatedso that air is expelled to fully hydrate the device.

If the container is a bladder, the activating member may be a piercingelement such that an external force applied to the package causes thepiercing member to pierce through or puncture the receptacle and thebladder, thereby release the hydrate within the bladder to the device.

As an alternative to activation of the activating member by manualmeans, for example, the activating member could be subjected to amechanical force exerting device and be activated automatically. Forexample, rollers, punches or the like may be used to exert a mechanicalforce.

The container 16 may contain elements other than a hydrate. For example,rather than a hydrate, the container 16 may contain a sterilizing agent,an activating agent such as, but not limited to, a catalyst, a cleaningagent, a coloring agent or the like. Embodiments of the presentinvention may be used to not only hydrate devices, but to provide anytype of interaction between a device and the element contained withinthe container 16. For example, a coloring agent may be contained withinthe container 16 such that, when the activating member 14 is activatedwithin the container 16, a liquid-liquid, liquid-powder, liquid-solid orthe like chemical reaction begins, thereby providing a visual change. Inother embodiments, a cleaning agent may be contained within thecontainer 16 such that, when a force is exerted on the activating member14, the container releases the cleaning agent to the device, therebycleaning the device.

A generalized packaging system 100 according to an embodiment of thepresent invention is shown in FIG. 11. The packaging system 100includes, without limitation, an enclosure 102, an activating member112, a substance container 108 and a receptacle 104 that includes anaperture 110. The enclosure 102 may allow sterilant penetration, but notmicrobe penetration, and generally includes enough space within itsinterior to house a device requiring hydration 106 in addition to theother elements of the packaging system 100. For example, in theembodiment shown in FIG. 11, the device requiring hydration 106 may be acatheter having a sensing element which must be hydrated.

Operation of the packaging system 100 shown in FIG. 11 may be asfollows. A sterilant or other hydrant may be contained in the substancecontainer 108. When it is desired to hydrate the device requiringhydration 106, the enclosure 102, which is sealed, may be inserted intothe aperture 110 located in the receptacle 104 so that the substancecontainer 108 is disposed below the activating member 112. A force F maythen be exerted upon the activating member 112 such that it crushes thesubstance container 108, thereby releasing the hydrant contained withinthe substance container 108, without compromising the integrity of theenclosure 112. The hydrant may then inundate the device requiringhydration 106, thereby hydrating the device 106, without exposing thedevice 106 to external contaminants.

A generalized packaging system 120 according to another embodiment ofthe present invention is shown in FIG. 12. The packaging system 120includes, without limitation, an enclosure 124, a reservoir 122containing a sterilant or other hydrate, a tube 126 and a valve 130. Theenclosure 124 may allow sterilant penetration, but not microbepenetration, and generally includes enough space within its interior tohouse a device requiring hydration 128 in addition to the other elementsof the packaging system 120. For example, in the embodiment shown inFIG. 12, the device requiring hydration 128 may be a catheter having asensing element which must be hydrated.

In the embodiment of the invention shown in FIG. 12, the reservoir 122containing the sterilant or other hydrate resides outside the enclosure124. The sterilant may be released from the reservoir 122 through thetube 126 by operation of the valve 130 and into the enclosure 124,thereby hydrating the device requiring hydration 128. The tube 126 orvalve 130 may then be sealed, for example, by heat sealing or othermethods, so that the enclosure 124 is sealed off from externalcontaminants.

According to embodiments of the present invention, air may be expelledfrom the enclosure within which the device requiring hydration isdisposed. By expelling air from the enclosure, the device requiringhydration may be effectively hydrated.

Embodiments of the packaging system described herein may be employed ina variety of applications. For example, if the device requiringhydration is an in vivo sensing element that has been sterilized and thepackage has been hermetically sealed, the device manufacturer could thenhydrate the sensing element after sealing the package by activating theactivating member through the package. Because there is no need to openthe package to hydrate the sensing element, the sterilization of thesensing element need not be compromised.

If the device requiring hydration is some other element that requireshydration for activation, the user could order and store a plurality ofthe packaging systems and activate the activating member only when thedevice is needed. For devices whose efficacy slowly diminishes over timeonce they have been hydrated, the shelf life of such devices will havebeen greatly increased. The devices may remain on the shelf in aninactivated state. The devices may then be hydrated by activating theactivating member through the package at such time as they are needed.

While particular embodiments of the present invention have been shownand described, it will be obvious to those skilled in the art that theinvention is not limited to the particular embodiments shown anddescribed and that changes and modifications may be made withoutdeparting from the spirit and scope of the appended claims.

1-32. (canceled)
 33. A packaging method comprising: providing a packageconfigured to be supported on a surface generally extending along an x-yplane; enclosing a first element with an enclosure; containing a secondelement in a container operable to selectively release the secondelement from the container; and positioning the container and theenclosure in the package such that the container rests at an elevatedposition above a position of the first element, along a directiongenerally perpendicular to the x-y plane, when the package is supportedon the surface, wherein the elevated position of the container withrespect to the position of the first element facilitates directing ofthe second element to move toward the first element upon release of thesecond element from the container, when the package is supported on thesurface.
 34. The method of claim 33, wherein the package comprises asurface, wherein the packaging method further comprises positioning abase on the surface of the package, and wherein positioning thecontainer and the enclosure in the package comprises supporting thecontainer on the base.
 35. The method of claim 34, wherein the surfaceof the package generally extends along the x-y plane.
 36. The method ofclaim 34, wherein the base has a sloping surface angled with respect tothe x-y plane, and wherein supporting the container on the basecomprises supporting the container on the sloping surface of the base.37. The method of claim 36, wherein at least one portion of the slopingsurface of the base is located between the container and the firstelement.
 38. The method of claim 37, wherein the least one portion ofthe sloping surface is configured to facilitate the directing of thesecond element to move toward the first element upon release of thesecond element from the container, when the package is supported on thesurface.
 39. The method of claim 38, wherein the at least one portion ofthe sloping surface is sloped downward towards the first element, alongthe direction generally perpendicular to the x-y plane, when the packageis supported on the surface.
 40. The method of claim 33, wherein thesecond element comprises a hydrate, and wherein the method furthercomprises expelling air from the enclosure to facilitate a hydration ofthe first element upon release of the second element from the container,when the package is supported on the surface.
 41. The method of claim33, further comprising: providing a mesh filter; and covering at least aportion of the container with the mesh filter.
 42. The method of claim41, wherein at least a portion of the mesh filter is located between thecontainer and the first element.
 43. The method of claim 41, wherein themesh filter is configured to filter the second element during themovement of the second element toward the first element upon release ofthe second element from the container, when the package is supported onthe surface.
 44. A method for hydrating an end portion of a catheter atwhich a hydratable element is disposed, the end portion of the catheterextending less than the entire length of the catheter adjacent to adistal end of the catheter, the hydrating method comprising: containinga hydrate in a container; receiving the container and the end portion ofthe catheter in an interior of a receptacle while the rest of thecatheter is disposed outside of the receptacle; and enclosing thereceptacle in an enclosure having an interior; wherein the container isoperable to release the hydrate to the end portion of the catheter whenthe end portion of the catheter is received within the receptacle, andwherein the container is arranged relative to the receptacle such thatupon the release of the hydrate from the container, the hydrate travelstoward the end portion of the catheter, contacts the end portion of thecatheter and is inhibited from contacting other portions of the catheterwhen the end portion of the catheter is received within the receptacle.45. The method of claim 43, further comprising causing the container torelease the hydrate by exerting force on an activating member to causesthe container to break or rupture.
 46. The method of claim 43, furthercomprising: placing a base inside a package; supporting the receptacleon the base; and arranging an activating member adjacent the receptaclein a position to transfer a force exerted on an exterior portion of thepackage through the activating member to the receptacle, to cause thecontainer to release the hydrate.
 47. The method of claim 43, furthercomprising: placing a base in the package, the base having a slopingsurface, and supporting the receptacle on the sloping surface of thebase.
 48. A packaging method for bringing elements located in a packageinto contact with each other, the packaging method comprising: enclosinga first element with an enclosure; containing a second element in acontainer located within a package adjacent to the first element, thecontainer operable to selectively release the second element from thecontainer; and arranging a receptacle for capturing the second elementupon release of the second element from the container; wherein thecontainer and the enclosure are arranged relative to each other andoperable such that upon release of the second element from thecontainer, the second element travels by gravity to and contacts thefirst element while the first element is enclosed within the enclosure.49. The method of claim 47, further comprising causing the container torelease the second element by exerting force on an activating member tocauses the container to break or rupture.
 50. The method of claim 47,further comprising: placing a base inside a package; supporting thereceptacle on the base; and arranging an activating member adjacent thereceptacle in a position to transfer a force exerted on an exteriorportion of the package through the activating member to the receptacle,to cause the container to release the hydrate.
 51. The method of claim47, further comprising: placing a base in the package, the base having asloping surface, and supporting the enclosure on the sloping surface ofthe base.
 52. The method of claim 47, further comprising: placing thereceptacle in a package hermetically sealing the package; andsterilizing the first element before causing the container to releasethe second element to the first element.